BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEULASTA OBI

    MDR report key: 12786274 · Received November 10, 2021

    Report

    Report Number
    12786274
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    July 20, 2021
    Report Date
    November 9, 2021
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE FROM STAFF: PATIENT HAD QUESTIONABLE INJECTION OF NEULASTA OBI ON CYCLE #1 OF CHEMO. PATIENT CALLED IN AND REPORTED FAILURE OF DEVICE. UNCLEAR IF IT WAS ADDRESSED BY COVERING PROVIDER. PATIENT WAS SUBSEQUENTLY ADMITTED FOR SEPSIS AND HAD SUBSEQUENT CYCLES OF CHEMOTHERAPY DOSE REDUCED. OUR TEAM WAS INFORMED OF THIS EVENT LAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687851 NEULASTA OBI INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. 1131930D

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Female